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Phase 3 Trial Initiated To Evaluate Safety, Efficacy of Mifepristone in Psychotic Major Depression
"We are pleased to have begun the third Phase III trial for our lead development program," said Dr. Joseph K. Belanoff, Corcept's chief executive officer. "PMD is a disorder that affects approximately three million people in the United States each year and for which there are no FDA-approved treatments. We look forward to determining the efficacy and safety of CORLUX. Through these studies, we are investigating whether CORLUX provides rapid and sustained relief from the psychotic symptoms of this severe illness."
Clinical Trial Design
The primary endpoint for this randomized, double-blind, placebo-controlled Phase III clinical trial of CORLUX, known as Corcept 09, is the proportion of patients with at least a 50% improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both Day 7 and Day 28. A secondary endpoint is a 50% or greater improvement in BPRS PSS at both Day 7 and Day 56, which is identical to the primary endpoints of the company's other two ongoing Phase III studies. The BPRS is an 18-item rating instrument used to assess psychopathology and the PSS includes the four items in the BPRS that specifically measure psychosis. In all three trials, patients must have at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the studies and will be hospitalized if clinically necessary. BPRS PSS assessments will also be made at Days 14, 28 and 42.
Corcept 09 is the company's first study to be conducted in Europe. This study will enroll up to 280 patients at approximately 15 sites in Croatia, Bulgaria and Serbia with a randomized one-to-one distribution into either a CORLUX or a placebo arm. Patients will receive either 600 mg of CORLUX or placebo once daily for a period of seven days. Concurrent with the first day of dosing, all patients will receive antidepressant therapy through Day 56. No patient will be allowed to take either antidepressant or antipsychotic medication for at least one week before beginning the seven day treatment period. Treatment with antipsychotic medications or electroconvulsive therapy will not be allowed at any time during the study
Previously completed trials
The Company has completed four studies of CORLUX for the treatment of psychotic features of PMD. In January 2001, a dose finding clinical trial evaluating the efficacy, tolerability and dose response of CORLUX showed that after one week of treatment, approximately two-thirds of the patients in the two higher dosage groups (600 mg and 1200 mg) experienced clinically meaningful reductions in psychosis, as measured by the BPRS. Based on these encouraging results, the Company conducted two clinical trials, the 02 study and 03 study, which were double-blind, placebo-controlled safety and efficacy studies in which a total of 429 patients were enrolled.
The 02 study showed that CORLUX was well tolerated and that there were no discernible problems with drug interactions between CORLUX and commonly prescribed antipsychotic and antidepressant medications. The 03 study demonstrated with statistical significance that patients in the CORLUX group were more likely than patients in the placebo group to achieve a 50% reduction in the BPRS PSS at Day 7 sustained to Day 28. In a fourth trial, an open label study of the safety of retreatment in patients with a favorable response to treatment in the 02 and 03 studies, it was indicated that patients tolerated their retreatment well. Twenty-eight patients participated in this study.
About Psychotic Major Depression
PMD is a serious psychiatric disorder that affects approximately three million people annually in the United States. It is more prevalent than either schizophrenia or manic depressive illness. The disorder is characterized by severe depression accompanied by delusions, hallucinations or both. People with PMD are approximately 70 times more likely to commit suicide than the general population and often require lengthy and expensive hospital stays. There is no FDA-approved treatment for PMD.
Source: Corcept Therapeutics Incorporated